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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583401
Expanded Access Status : No longer available
First Posted : December 31, 2007
Last Update Posted : February 4, 2019
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.

Condition or disease Intervention/treatment
Patent Foramen Ovale Stroke Device: Device closure with the AMPLATZER PFO Occluder

Detailed Description:
The primary objective of the PFO Access Registry is to allow access to the AMPLATZER PFO Occluder in subjects with a PFO who have already experienced at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy.

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Patent Foramen Ovale Closure With the AMPLATZER PFO OCCLUDER in Patients With Recurrent Cryptogenic Stroke Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale Who Have Failed Conventional Drug Therapy

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Device closure with the AMPLATZER PFO Occluder
    Device closure with the AMPLATZER PFO Occluder

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy

Exclusion Criteria:

International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)

No Contacts or Locations Provided

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Responsible Party: Abbott Medical Devices Identifier: NCT00583401     History of Changes
Obsolete Identifiers: NCT00557479
Other Study ID Numbers: AGA-011
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

Keywords provided by Abbott Medical Devices:

Additional relevant MeSH terms:
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Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities